Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Asfotase alfa
Drug ID BADD_D00174
Description Asfotase alfa is a first-in-class bone-targeted enzyme replacement therapy designed to address the underlying cause of hypophosphatasia (HPP)—deficient alkaline phosphatase (ALP). Hypophosphatasia is almost always fatal when severe skeletal disease is obvious at birth. By replacing deficient ALP, treatment with Asfotase Alfa aims to improve the elevated enzyme substrate levels and improve the body's ability to mineralize bone, thereby preventing serious skeletal and systemic patient morbidity and premature death. Asfotase alfa was first approved by Pharmaceuticals and Medicals Devices Agency of Japan (PMDA) on July 3, 2015, then approved by the European Medicine Agency (EMA) on August 28, 2015, and was approved by the U.S. Food and Drug Administration (FDA) on October 23, 2015. Asfotase Alfa is marketed under the brand name Strensiq® by Alexion Pharmaceuticals, Inc. The annual average price of Asfotase Alfa treatment is $285,000.
Indications and Usage Indicated for the treatment of patients with perinatal/infantile and juvenile onset hypophosphatasia (HPP).
Marketing Status approved; investigational
ATC Code A16AB13
DrugBank ID DB09105
KEGG ID D10595
MeSH ID C570710
PubChem ID Not Available
TTD Drug ID D05XSJ
NDC Product Code 25682-013; 67643-0017; 25682-016; 25682-019; 25682-010
UNII Z633861EIM
Synonyms asfotase alfa | ENB-0040 | Strensiq
Chemical Information
Molecular Formula Not Available
CAS Registry Number 1174277-80-5
SMILES Not Available
Chemical Structure
ADRs Induced by Drug
*The priority for ADR severity classification is based on FAERS assessment, followed by the most severe level in CTCAE rating. If neither is available, it will be displayed as 'Not available'.
**The 'Not Available' level is hidden by default and can be restored by clicking on the legend twice..
ADR Term ADReCS ID ADR Frequency (FAERS) ADR Severity Grade (FAERS) ADR Severity Grade (CTCAE)
Vitamin B6 decreased13.02.05.003--Not Available
Vomiting07.01.07.003--
Lipodystrophy acquired23.07.01.003; 14.08.04.008--Not Available
Injection site cellulitis23.11.02.012; 12.07.03.037; 11.02.01.012; 08.02.03.037--Not Available
Contusion12.01.06.001; 15.03.05.007; 24.07.06.001; 23.03.11.002--
Nodule08.03.05.002--Not Available
Injection site calcification08.02.03.043; 12.07.03.043--Not Available
Hypoaesthesia oral17.02.06.021; 07.05.05.003--Not Available
Injection site scar23.03.11.016; 12.07.03.050; 08.02.03.050--Not Available
Induration08.01.03.020--Not Available
Lipohypertrophy23.07.01.005; 14.08.04.009--
Injection site papule23.03.03.045; 12.07.03.031; 08.02.03.031--Not Available
Adverse reaction08.06.01.018--Not Available
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